Left Atrial Appendage Closure Registry of Henri Mondor Hospital

Recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT05565209
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Intro: Patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to strokes or systemic embolisms. This risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. Percutaneous left atrial appendage closure, is an interventional cardiology technique for patients at high risk of stroke related to atrial fibrillation in whom long term anticoagulation therapy cannot be conducted. This procedure involves implantation of an occlusion device into the left atrial appendage to close it and prevent migration of thrombotic material that could otherwise cause distant embolism. Closure of the left atrial appendage avoids long-term prescription of anticoagulants while protecting patients against the risk of systemic embolism and stroke.

Hypothesis/Objective: the main objective of this study is to assess the long term efficacy of left atrial closure, 5 years after the procedure Method: 150 patients will be included prospectively. We will also include restropectively100 other patients, previously treated by left atrial appendage closure at Henri Mondor hospital. Demographic, clinical, echocardiographic, and computed tomography data will be obtained by physical examination or medical records.

Conclusion: this study will allow to assess the long term efficacy of left atrial closure in atrial fibrillation patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-15
• Study Start: 2022-09-24
• Study First Submitted QC: 2022-10-03
• Study First Posted: 2022-10-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-06
• Primary Completion: 2026-09-14
• Study Completion: 2026-09-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Any patient for whom an indication has been made for implantation of a device for the closure of the left atrial appendage without restriction of indication and regardless of the outcome of the procedure (implantation success or not)

Exclusion Criteria

• Refusal of the patient to participate in this study
• Minor patient
• Patient not affiliated to the French social security system

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of thrombo-embolic events	60months of follow-up after the procedure	The primary efficacy endpoint is the frequency of a combined endpoint including ischemic strokes and systemic embolisms after left atrial appendage closure. This frequency will be expressed as the percentage of patients who presented at least one of these events. Only the first event occurring in each patient will be taken into account, in the case where the same patient would present several events.

Secondary Outcome Measures

Name	Time	Method
Percentage of transient ischemic attack (TIA)	1 and 5 years after the procedure	Percentage of patients presenting at least one systemic embolism during the study
Percentage of device thrombosis	3 months; 1 year; 5 year	Percentage of patients who presented a thrombosis on the device, objectified by transesophageal echography and / or CT scan
Percentage of ischemic stroke	1 and 5 years after the procedure	Percentage of patients with at least one ischemic stroke during the study
Comparison of the rate of thromboembolic events to expected values	1 and 5 years after the procedure	the observed rate of thromboembolic event will be compared to the expected value, according the individual patients CHA2DS2-VASc scores
Bleedings not-related to the procedure or the device	1 year; 5 year	Percentage of patients who presented a bleeding not-related to the procedure or the device
Occlusion of the left atrial appendage	3 months	The percentage of left atrial appendage occlusion is defined as the percentage of patients where left atrial appendage is efficiently closed at by transesophageal echography and / or CT scan Time Frame: 3 months
Percentage of systemic embolism	1 and 5 years after the procedure	Percentage of patients presenting at least one systemic embolism during the study
Bleeding (all cause)	1 year; 5 year	Percentage of patients who presented a bleeding
residual peri-device leak	3 months	The percentage a patients with 3 months residual peri-device leak will be determined at transesophageal echography and / or CT scan
All-cause mortality	1 and 5 years after the procedure	percentage of all cause deaths
Percentage of migration of the device	3 months; 1 year; 5 years	: Percentage of patients who presented a migration of the device, objectified by the echocardiography and / or CT scan
Criteria for Evaluating Associated Antithrombotic Treatments	: Discharge, 3, 6, 12 months after the procedure, 1 and 5 years after the procedure	The antithrombotic treatments will be collected at different follow-up times.; The type and duration of anti-thrombotic treatments will be documented using the combined criteria: * Percentage of patients on injectable or oral anticoagulants and antiplatelet agents at different follow-up times; * Percentage of patients on injectable or oral anticoagulants at different follow-up times; * The percentage of patients on platelet antiaggregants in single or dual therapy at different follow-up times
Description of the population	At inclusion	Demographic and clinical characteristics of the patients will be collected and described, such as: age, sex, medical and surgical history, cardiovascular pharmacological treatments, comorbidities, indication of left atrial closure, HAS-BLED and CHA2DS2-VASc scores, anatomical features of the left atrial appendage at inclusion.
Efficacy of the procedure	One hour after the end of the procedure	: At the end of the procedure, the efficiency of the procedure will be described by the percentage of success of the procedure. The successful procedure is defined by a successful implantation of the device in the left atrial appendage without presaging its occlusive character.; One hour after the end of the procedure
Cardiovascular or unexplained death	1 and 5 years after the procedure	Percentage of patients who had a cardiovascular or unexplained death during the study
Rate of complications related or potentially related to the device or the implantation procedure	periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)	: Rate of complications related or potentially related to the device or the implantation procedure
Percentage of pericardial effusion	3 months	Percentage of patients who presented a pericardial effusion objectified by trans-thoracic ultrasound

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR; 🇫🇷 Créteil, France